National Animal Health Laboratory Network Strategic Plan 2022-2025 - USDA APHIS

Page created by Connie Carrillo
 
CONTINUE READING
National Animal Health Laboratory Network
             Strategic Plan 2022-2025
PREFACE
•   The National Animal Health Laboratory Network (NAHLN) was developed in response to the Public
    Health Security and Bioterrorism Preparedness and Response Act of 2002, and the Homeland
    Security Presidential Directive/HSPD-9 of 2004 to “develop nationwide laboratory networks for
    food, veterinary, plant health and water quality that integrate existing Federal and State laboratory
    resources, are interconnected, and utilize standardized diagnostic protocols and procedures”.
•   The NAHLN enables Federal and State laboratories to test for economically devastating and
    potentially zoonotic diseases such as foot-and-mouth disease, African swine fever, influenza in avian
    and swine species, and bovine spongiform encephalopathy (BSE) among other NAHLN scope
    diseases. It serves as our nation’s most vital early warning system for emerging and foreign animal
    diseases.
•   Adequate funding of the NAHLN directly addresses our nation’s need for a safe, stable, and
    nutritious food supply, and enables preparation, prevention, diagnosis, response, and recovery from
    economically important and potentially zoonotic diseases.

VISION
The National Animal Health Laboratory Network (NAHLN): a network of animal disease diagnostic
laboratories that works effectively as a team, provides ongoing disease surveillance, responds quickly to
disease events, communicates diagnostic outcomes to decision makers in a timely manner, and has the
capability and capacity to meet diagnostic needs during animal disease outbreaks.

MISSION
The NAHLN is a nationally coordinated network and partnership of Federal, State, and university-
associated animal health laboratories. NAHLN laboratories provide animal health diagnostic testing,
methods research and development, and expertise for education and extension to detect biological
threats to the nation’s animal agriculture, thus protecting animal health, public health, and the nation's
food supply.

KEY Principles
The NAHLN will:
• Maintain the capability and capacity to provide nationwide laboratory services in support of early
    detection and response to foreign animal disease outbreaks or another adverse animal health
    events.
• Assess the health and well-being of the country’s livestock population through active and passive
    diagnostic surveillance testing for exotic, emerging, and zoonotic diseases of animals.
• Operate within a quality management system that meets American Association of Veterinary
    Laboratory Diagnosticians (AAVLD), International Organization for Standardization (ISO) 17025, or
    equivalent standards.
• Use standardized protocols, reference materials, and equipment.
• Use facilities that maximize biosafety, biosecurity and physical security requisite for testing
    performed.

                                                                                                             1
•   Support the development, validation, and deployment of critical animal disease diagnostic testing
    methods through research and data exchange.
•   Provide national animal disease diagnostic technical proficiency testing through the National
    Veterinary Laboratory Services (NVSL).
•   Establish and maintain uniformly trained and competent animal disease diagnostic laboratory
    personnel.
•   Provide national diagnostic laboratory quality management system training.
•   Support the development of a system of “first detectors” through training of private veterinarians,
    extension educators, producers, and state and federal animal health officials.
•   Establish and implement secure, rapid electronic communications systems to optimize reporting,
    alert, and epidemiological needs.
•   Evaluate animal health emergency preparedness through scenario testing to identify and prioritize
    testing and communication gaps.
•   Assess the need for optimized and flexible network capacity.

NAHLN Strategic Priorities for next 3 years

    1. Disease Detection, Outbreak Response and Surveillance- The purpose of the NAHLN is
       to provide early detection, rapid response, and appropriate recovery from an adverse
       animal health event. Activities supporting the priority focus on identification of high-
       consequence pathogens including those that are transboundary/foreign animal diseases
       (FAD), endemic to the US or newly emerging diseases. The objectives within this priority
       are grouped based on their relevance to these three disease categories.

    General activities
    o Continue to provide basic activities that support the purpose of NAHLN- early detection,
       rapid response, and appropriate recovery of a high-consequence animal disease.
    o Identify a second Vendor for all platforms and reagents.
    o Harmonize protocols within and across diseases as much as possible.
    o Engage the NAHLN Coordinating Council, laboratories, and others to develop a standard
       methodology to define and measure capacity.
    o Work with Vendors to develop enhanced access to materials needed during an outbreak.
    o Participate in drafting a POC testing policy for consideration based on the
       recommendations from the MTWG subgroup.
    o Participate in and support developing strategies to streamline and harmonize PTs
       utilizing the recommendations of the MTWG subgroup.
    o Provide guidance for incident management teams regarding the involvement of NAHLN
       laboratories in the ICS.
    o Exercise scenarios that incorporate specific response activities.
    o Support AMR surveillance as a permanent program based on funding assurance
       separate from that supporting disease surveillance and response.

                                                                                                          2
Activities specific to Transboundary diseases (FAD)
   o   Support the evaluation of aggregate sampling for FAD testing.

Activities specific to high-impact Endemic diseases
    o Support the development of protocols to handle look- alike disease testing.
    o Support collaborative activities to evaluate new technologies.

Activities specific to Emerging diseases
    o Review and implement minimum standards provided by NVSL reference laboratories for
        the evaluation of sequencing data.
    o Support and develop the NBAF Partnering Program to enhance regional response and
        interaction to better prepare for potential emerging pathogens.

2. Coordinate the effort to determine resource needs for NAHLN- among APHIS-VS, National
   Institute for Food and Agriculture (NIFA) and AAVLD partners through stakeholder input and
   communication.

General activities
   o Complete an annual Business Plan to identify specific activities to be accomplished and
      document contribution of NAHLN laboratories.
   o Continue interagency coordination of noncompetitive funding with NIFA for NAHLN
      laboratory infrastructure support.
          • Determine if there are options to provide funding from each Federal source
               (APHIS and NIFA) in a more consistent manner and with less of a burden on both
               agencies.
   o Assess effectiveness of current NAHLN structure including Level designations.
   o Complete an economic impact study for the NAHLN.
   o Determine prioritized list of activities based on strategic plan for consideration should
      additional funding become available.

Activities specific to NAHLN Laboratories
    o Identify ways to increase the value of NAHLN participation in non-monetary ways (e.g.,
        collaborative laboratory/Federal efforts and opportunities to participate in technical
        projects).
    o Support 2018 Farm Bill efforts
            • Review deliverables for Farm Bill projects to determine how best to use results
               to benefit the network.
            • Develop long term priorities
    o Fully participate in ARP act- fulfill NAHLN Role in this opportunity

                                                                                                 3
3. Standardized data capture and electronic messaging- continue to improve the capability of
NAHLN laboratories to electronically message test results. Standardize the process of
developing a message across diseases and integrate with other Federal systems, as well as key
external systems.

General activities
   o Develop recommendations for stabilizing messaging based on a collaborative summit
      meeting including NAHLN, VS (commodity staff, CFI, CEAH, IMT), SAHO and others as
      appropriate.
   o Develop and communicate a messaging policy so the expectations surrounding
      messaging are understood.
   o Continue to collaborate with NVSL to increase messaging capabilities and integration
      with LMS and other systems including EMS.
   o Expand capability for USDA-APHIS Veterinary Services diseases to be messaged.
          • Integrate with other systems as required including CLSM and NLRAD
   o Develop a method(s) to monitor data quality in real-time using a blend of automated
      tools and human oversight.
          • Identify an approach that utilizes automation, to the extent that NAHLN Program
               Office, S&P, Center for Informatics; and, USDA, OCIO, CEC staff concur, to reduce
               the burden on VS staff to perform messaging quality control activities.

4. Integrate with and support animal health community long-term initiatives- including but
not limited to: One Health approach to surveillance and response, the National Action Plan for
Combating Antibiotic-Resistant Bacteria, business continuity plans for commodities and meats;
comprehensive and integrated surveillance initiatives; participation in the Integrated
Consortium of Laboratory Networks; and develop outreach materials to develop a better
understanding of the role of NAHLN.

General activities
   o Participate in Secure Food Plans including defining and communicating the role of
      NAHLN labs in their implementation
   o As part of NVSL, support efforts to build Swine Health Improvement Plan
          • add to business plan- consider if similar programs for bovine, aquaculture
   o Support Antimicrobial Resistance studies utilizing NAHLN laboratories
          • Assure funding independent from NAHLN operational funds
          • Collaborate with other AMR groups- FDA (Vet-LIRN, NARMS, etc.)
   o Support current NPIP and interactions associated with Low-path IAV-A.
   o Continue working within the Integrated Consortium of Laboratory Networks (ICLN)
   o Support collaborations with other Federal Partners for a One Health approach.
   o Explore international collaborative opportunities
          • Individual networks in other countries
          • Initiate outreach to North American Animal Health Laboratory Network
               (NAAHLN) add to business plan

                                                                                                 4
o Develop relevant information materials about NAHLN and provide to external
      stakeholders. Engage with and educate industry representatives and producers on the
      benefits of NAHLN in the event of an outbreak.

•   5. Continuation of codification activities - develop 9CFR language; submit and complete
    codification process.

General activities
   o Finalize program standards.
   o Define and follow the current process for obtaining codification.
Determine what parts of NAHLN would benefit from a Rule and what parts do not need to be
codified.

                                                                                              5
APPENDIX A-- Strengths, Weaknesses, Opportunities and Threats
Strengths
•   Demonstrates success as a State/Federal partnership for over ten years
•   Nationally coordinated network of almost all publicly funded animal disease diagnostic laboratories
•   Coordinating Council made up of Federal and State partners
•   Standardized and regularly audited quality system requirements in NAHLN laboratories
•   Laboratory facilities with significant BSL-2 and BSL-3 capabilities and capacities
•   Secure communications for data reporting and alert notifications
•   Developed and implemented NAHLN IT system for HL7 messaging
•   Unmatched national resource of expertise in animal disease diagnostics and facilities
•   Standardized, practical assays deployed for fourteen important infectious animal diseases
•   Laboratory staff that is proficiency trained and tested for use of deployed assays
•   Demonstrated competence in national animal disease surveillance efforts
•   Productive alliances established with other national laboratory networks through the integrated
    consortium of laboratory networks (ICLN)
•   Name recognition in important parts of the Executive Branch, Congress, and industry
•   Partnering with AAVLD accreditation program to provide maximum effectiveness, economy, and
    efficiency
•   NAHLN Methods Technical Working Group provides essential and effective network-wide input into
    test development and validation
•   NAHLN Exercises and Drills Working Group develops and/or supports the participation of NAHLN
    laboratories in local, regional, and National exercises and drills to increase preparedness
•   Network laboratories have diagnostic expertise and testing capabilities to diagnose known and
    emerging infectious and non-infectious diseases.

Weaknesses
•   Based on disease and its route of incursion, there may potentially be inadequate resource
    availability
•   Lack of trained personnel
•   Efficient and timely data collection and electronic messaging not standardized across laboratories
    due to range of available expertise and resources
•   Decreased on-going surveillance programs due to reduced Federal funding
•   Inability to secure adequate funding despite significant lobbying efforts

Opportunities
•   Potential for increased Federal funding for laboratory infrastructure and all NAHLN activities
    through Federal appropriations and other Federal and non-Federal sources including the Farm Bill
•   Potential for enhanced communications and alliances with other State and Federal partners and
    industry
•   Partner with Federal and non-federal partners for utilizing NAHLN infrastructure and data with the
    integration into on-going national scale efforts such as swine comprehensive surveillance
    development, business continuity planning, enhanced passive surveillance, etc.
•   Enhance functionality and partnering with the Integrated Consortium of Laboratory Networks

                                                                                                         6
Threats
•   Level or decreased Federal funding of surveillance programs, directed testing, and laboratory
    infrastructure enhancements
•   Continued decreased level of State funding for support of laboratories and infrastructure
•   Outbreak of significant disease for which the NAHLN is not prepared, either through lack of
    capability (i.e., lack of diagnostics for known diseases) or lack of capacity (i.e., surge)
•   Lack of trained diagnosticians
•   Emergence of significant disease for which there are not developed or validated assays
•   Potential lack of cooperation between states, and between states and the federal government in the
    face of a significant disease event

                                                                                                    7
APPENDIX B—Abbreviations

AAVLD      American Association of Veterinary Laboratory Diagnosticians
AMR        Antimicrobial Resistance Monitoring
APHIS      Animal and Plant Health Inspection Service
ARP Act    American Rescue Plan Act
ASF        African Swine Fever
BSE        Bovine Spongiform Encephalopathy
BSL        Biological Safety Levels
CEAH       Center for Epidemiology and Animal Health
CEC        Client Experience Center
CFI        Center for Informatics
CLSM       Comprehensive Lab Submission Module
EDWG       Exercises and Drills Working Group
EMS        Enterprise Messaging Services
FAD        Foreign Animal Disease(s)
FMD        Foot-and-Mouth Disease
ICLN       Integrated Consortium of Laboratory Networks
IMT        Incident Management Team
ISO        International Organization for Standardization
LMS        Laboratory Messaging Services
MTWG       Methods Technical Working Group
NAAHLN     North American Animal Health Laboratory Network
NAHLN      National Animal Health Laboratory Network
NARMS      National Antimicrobial Resistance Monitoring System
NBAF       National Bio and Agro-Defense Facility
NIFA       National Institute for Food and Agriculture
NLRAD      National List of Reportable Animal Diseases
NPIP       National Poultry Improvement Plan
NVSL       National Veterinary Laboratory Services
OCIO       Office of the Chief Information Officer
POC        Point of Care
PT         Proficiency Test
S&P        Strategy & Policy
SAHO       State Animal Health Official(s)
SHIP       Swine Health Improvement Plan
Vet-LIRN   Veterinary Laboratory Investigation and Response Network
VS         Veterinary Services

                                                                          8
You can also read